New Drug ATL1102 Comparable to Tysabri?

In the very recent years we have seen a number of new MS therapies approved for use in managing Relapsing Remitting Multiple Sclerosis (RRMS) such as Gilenya and Tecfidera (which may or may not have dangerous long term effects; some people/doctors feel these medications were rushed out onto the market). Most pharmaceutical companies have been moving away from injectable medications and towards the more “convenient” oral medications because let’s face it, who likes needles? Well as of now a new medication for RRMS created by Antisense Therapeutics has finished it’s phase IIa clinical trial testing. This medication is currently called ATL1102 (kind of catchy right?) and is claimed to have results “as good as, or superior to, those achieved with MS drug Tysabri”.

For those of you who do not know, Tysabri (Natalizumab) is a monoclonal antibody given once every 4 weeks via intravenous (IV) infusion. It has been shown to reduce relapse rates by 67% over a 2-year period of time compared to 41% by placebo. Of the 627 people who participated in this study, more than 6 out of 10 people had no flare ups at all! Another important factor (that is sometimes overlooked by patients) is that Tysabri greatly reduces the long-term disability of MS; People taking Tysabri were about 42% less likely to develop a worsening of physical disability. Regarding brain lesions, about 97% of the people participating in this study showed no new lesions over the 2 year study!

Tysabri is generally well tolerated but is often used as a sort of “last resort” when no other therapies prove to be effective in managing someone’s disease because of one rare (but sometimes fatal) brain infection that Tysabri can cause you to develop. This brain infection is called Progressive Multifocal Leukoencephalopathy (PML) and there are several factors to help determine your odds of developing PML which include length of time on Tysabri, prior use of immunosuppressants, and whether you are JCV (John Cunningham Virus) positive or not. Though some might say that the risk is not that great (less than 1/1,000 if you have been on Tysabri less than 24 months and have no other risk factors) most people hear “fatal brain infection” and are scared away.

According to the studies that have been done on ATL1102, we can supposedly expect results that are just as good (if not better) than Tysabri and possibly without the potential side effects like PML or some of the possible long term side effects of other MS medications. That is a pretty large claim if you ask me but I am definitely interested! On top of that, this medication is planned to be self administered by injections rather than IV which some may feel is more convenient than having to drive in to an infusion center once a month.

As someone who is currently taking Tysabri, I am interested to see what further clinical trials reveal. I have been keeping an eye on Lemtrada (Alemtuzumab), which was originally used to treat Leukemia under the name Campath, but now that ATL1102 is in the picture I’ll have to divide my attention between the two as I am just about at the 24-month mark with Tysabri (plus I am JCV positive) so I have to start planning my next coarse of therapy out. Unfortunately there is not too much information available on ATL1102 just yet, at least not any information that most of us would care about, but I will definitely be writing about this as more information comes in. Antisense Therapeutics is currently seeking FDA guidance on the submission of ATL1102 and the FDA plans to respond to this request by the end of October 2014 but it’s uncertain when more information on ATL1102 will become available.

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Comments

I’ve been on Tysabri for over 7 years now, and just last year tested JCV+. My titer levels, however, are considered in the “indeterminate” category at 0.26%, which means that I’m comfortable remaining on Tysabri until something with the same level of efficacy or better comes on the market.

Thankfully, I’ve overcome the issue with needles (during my Avonex and Rebif days), and would much rather something like that than the oral meds, which I could not tolerate at all. Additionally, I’ve been clinically stable on Tysabri and consider it to be the platinum category of MS DMTs.

I agree I have been WAY STABLE on Tysabri, so though I tested positive on the ELISA test for the JCV, and they SAY my titter is high (I forget the number but I don’t trust them one bit) I am comfortable staying on it till I find something new.

I was looking at Campath/Lemtrada but now that this one is being worked on it’s kind of a matter of what comes out first unless my Neurologist in SoCal has an opinion on either or (which I will share when I get it).

I don’t miss needles but I don’t mind them at all and would rather an injection than a pill as I feel the delivery method is much better (doesn’t have to go through the filter known as the digestive system).

On my 54th Tysabri and my index of JC virus is less than 1% which means the PML threat is nominal…VERY nominal. I have a bigger chance of getting in a bad car accident. Someone at our center is on treatment 91 and tolerates magnificently. I’m hopeful the new drug does come through and work well as taking it at home would be convenient. FearlessMS

That is kind of what I told me new neuro when she wanted me off because I am now JC positive; I had a less than 1/1000 chance of developing MS before and now? I have a less than 1<1000 chance… I am not getting off yet. It would do me more harm to get off than stay on (statistically speaking).

I too am marking 24 months on Tysabrii. This drug has done wonders for me, thats why I would like to stay on it but the chances of getting PML scares me to death. My dr. has been very helpful & understanding about my fears.

I enjoyed reading your article about the new drug & hopefully it will be approved before I have to make a decision. Please keep us posted on what you find out.